EQS-Adhoc

Relief Provides Corporate Update and Outlines Plans to Advance its Diversified Portfolio of Pipeline Candidates, Including RLF-100(TM) (Aviptadil) - Seite 3

Relief is also working closely with its collaboration partner Acer Therapeutics on the preparations for a potential launch of ACER-001, a proprietary, taste-masked formulation of sodium phenylbutyrate for the treatment of Urea Cycle Disorders ("UCDs"). ACER-001 is the subject of a New Drug Application ("NDA") that has been accepted for review by the United States Food and Drug Administration ("FDA") with a Prescription Drug User Fee Act (PDUFA) approval decision action date of June 5, 2022. Additionally, Relief is preparing to submit a Marketing Authorization Application ("MAA") for ACER-001 to European and U.K. regulatory agencies, which is expected to be filed during the first half of 2022. Moreover, Relief intends to assess ACER-001 in a clinical program for Maple Syrup Urine Disease ("MSUD") during 2022. Relief and Acer also continue to explore strategic options to advance the optimization of ACER-001's commercial value in territories beyond the U.S., U.K. and Europe.

Other Initiatives

Relief intends to advance APR-TD011, a novel, proprietary, spray-based formulation of a hypotonic acid-oxidizing solution with established wound healing and anti-microbial properties, for epidermolysis bullosa ("EB"), a billion-dollar annual target market according to Knowledge Sourcing Intelligence. Relief believes that APR-TD011 could prove a transformative solution for EB patients, who suffer from debilitating pain due to large, chronic, constantly blistering skin wounds. APR-TD011 also inhibits the NF-kB pro-inflammatory pathway and by inactivating matrix metalloproteases, known to mediate wound inflammation. Relief believes that APR-TD011 could improve the quality of life of EB patients by accelerating wound healing and reducing the itching and pain linked to infections and inflammation.

Relief also possesses an array of other assets. These include SENTINOX, a novel nasal spray solution for upper airway infections with viral pathogens including the SARS-CoV-2 virus, the causal agent of COVID-19; Nexodyn AOS, an acid-oxidizing solution for treatment of chronic wounds (including foot ulcers); and the PHYSIOMIMIC platform-enabled amino acid-based product candidates for an array of rare metabolic disorders. Positive interim clinical data showing accelerated clearance of upper airway viral infection was recently reported for SENTINOX in a randomized, placebo-controlled clinical trial. SENTINOX was certified in Europe on February 16, 2021 as a Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.1).